NCT02385799

A Trial of Sertraline in Young Children With Autism Spectrum Disorder

A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Randi J. Hagerman, MD · Academic / Other
• Sex: All
• Age: 24 Months – 72 Months
• Healthy volunteers: Not accepted

Summary

This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.

Detailed description

This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder (ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a retrospective study has shown significant improvements in language and social deficits. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors. The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with ASD who are between the ages of 2 years and 5 years old inclusive. At baseline, the researchers will assess behavioral and cognitive development. Each participant will be involved in this trial for a period of six months. This will include three visits to the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side effects of the sertraline treatment throughout the study.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Sertraline Liquid Placebo	Liquid placebo given in parallel to active medication
DRUG	Sertraline	Active medication

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2015-03-11
• Last updated: 2019-10-22
• Results posted: 2019-05-09

Locations

1 site across 1 country: United States